A pool of citrated human plasma collected from a minimum of 20 donors that has been depleted of specific clotting factors. The plasma is buffered with 0.05M HEPES buffer and stabilizers,…
A pool of citrated human plasma collected from a minimum of 20 donors that has been depleted of specific clotting factors. The plasma is buffered with 0.05M HEPES buffer and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays (PT and APTT) in the highly abnormal range.
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1).
Record
Regulatory record for VisuCon-L Coag Screen ABN2 Plasma | Listed by | Affinity Biologicals Inc., Canada |
| FDA product code | GGN |
| Device type | Plasma, Coagulation Control |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5425 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-19 |
| Record revised | 2026-05-18 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2024-03-31 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.